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[VENCLEXTA LOGO]

VENCLEXTA is a prescription medicine used to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It is not known if VENCLEXTA is safe and effective in children.

Please see Important Safety Information throughout this video.

Please see Full Prescribing Information, including Medication Guide, on www.VENCLEXTA.com or at www.rxabbvie.com/pdf/venclexta.pdf.

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Danise

CLL Patient

Danise:           My name is Danise. I grew up in Chicago. We moved to New York in 1981 because of my husband’s job. We had three kids.

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This is Danise’s story. Individual results may vary.

Danise:           Kids grew up, went to school, I worked. Being a librarian is an incredibly interesting thing. It's never the same twice. We have been as a family, remarkably healthy.

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CLL Diagnosis

Danise:           2005, I went to my regular internist and he did a blood test as part of the examination. That's when he diagnosed the CLL. We didn't tell anybody. We didn't tell the kids, there were no symptoms. There was no outward sign. There were no lumps. There were no, you know, there was nothing to bring notice to it. What we did for, for nearly 10 years was just watch.

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CLL Progression

Denise:           My whole sense of how the disease was progressing was on the numbers that people told me. I'd go in and they say it's this, you know, you could chart it. It went ch ch ch ch ch. My lymph nodes never got swollen but my spleen did. My spleen was enormous.


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CLL Treatment

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Danise did not respond to chemotherapy.

Denise:           I did three rounds of chemo. And then after the third round, they tested my bone marrow and decided it wasn’t working.


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Nicole Lamanna, MD, Danise’s Oncologist

Dr. Lamanna is a paid consultant for AbbVie and Genentech.

NICOLE:        Given the fact that she had still a fair amount of disease after her chemo-immunotherapy, we were really hoping to really improve her response to on the order of more of a complete remission. She did not achieve that with chemo-immunotherapy. So the goal was to try to achieve that with a novel alternative agent because I didn't think switching her to another chemotherapy program was in her best interest.

Denise:           I was ready to try something. Yeah, yeah.

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Choosing VENCLEXTA

Nicole:             VENCLEXTA does a very good job at cleaning up the bone marrow involvement with the disease.

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VENCLEXTA + rituximab is completed in ~24 months.
 
Nicole:            When you think about a drug like VENCLEXTA, there’s no doubt the appeal for many patients is the time-limited duration.
 
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There are no out-of-pocket costs for VENCLEXTA + rituximab after completing treatment at the recommended dose. You may still incur out-of-pocket costs for other treatments or tests as directed by your healthcare provider.

Nicole:            And then there's a cost concern for patients.

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Treatment Efficacy

Danise is progression free because of VENCLEXTA + rituximab.

In a clinical study of 389 people with previously treated CLL, the primary measurement of the study showed the chance of disease worsening or death was 81% lower with VENCLEXTA + rituximab (194 people) than with the chemotherapy and antibody regimen (bendamustine + rituximab) (195 people). The median time that patients live without their disease worsening in patients who received the chemotherapy and antibody regimen was 18.1 months. The study has not yet been able to determine the median time that patients lived without their disease worsening for VENCLEXTA + rituximab because more than half of patients were both alive and had not yet experienced worsening of their disease.
 
Other secondary measurements of the study include remissions and minimal residual disease.

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Achieving Undetectable MRD with VENCLEXTA+GAZYVA is possible.

  • Complete remission means that all signs and symptoms of cancer have disappeared for a period of time, but cancer may still be in the body.
  • Complete remission with incomplete marrow recovery means all signs and symptoms of cancer have disappeared for a period of time, except that platelet, white blood cell, or red blood cell counts remained low.
  • Partial remission means the cancer was improved and there were fewer cancer cells present, but there was still evidence of the cancer in the body. Nodular partial remission means that most signs and symptoms of cancer disappeared for a period of time except for some remaining cancer cells in the bone marrow.

Remission is possible with VENCLEXTA + rituximab.

  • 92% of people achieved some level of remission (179 of 194) with VENCLEXTA + rituximab compared to 72% (141 of 195) with the chemotherapy and antibody treatment.
  • 8% achieved a complete remission or complete remission with incomplete bone marrow recovery (16 of 194) with VENCLEXTA + rituximab compared to 4% (7 of 195) with the chemotherapy and antibody treatment.
  • 82% of people achieved partial remission (160 of 194) with VENCLEXTA + rituximab compared to 68% (133 of 195) with the chemotherapy and antibody treatment.

Nicole:            Because she’s in complete remission and has no detectable disease, the frequency of monitoring is much less. She’s living her life because now it’s not you know, we don’t see each other that much.

Denise:           Right.

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Danise has no evidence of disease in her blood or bone marrow.
 
53% of people (103 of 194) had no detectable cancer in their blood 3 months after the end of combination treatment with VENCLEXTA + rituximab compared to 12% of people (23 of 195) with the chemotherapy and antibody treatment.
 
Nicole:            We have the ability to really detect much more microscopic at finer and finer levels, little residual cells of CLL and so she has no evidence of disease that we currently detect.
 
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After completing VENCLEXTA treatment, some people had such a low level of CLL cells (fewer than 1 cancer cell per 10,000 white blood cells) that the cells were not detectable by the usual clinical tests. This is known as undetectable minimal residual disease (MRD).
 
MRD measurements do not necessarily predict likelihood of experiencing progression-free survival, complete remission, or other outcomes.

The most common side effects of VENCLEXTA + rituximab were low white blood cell counts, diarrhea, upper respiratory tract infection, tiredness, and nausea.

Individual results may vary.

Denise:           Now, I don’t take it anymore. It's really great.

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Danise has completed VENCLEXTA + rituximab treatment and as of May 2020, she is progression free, living her life.

Denise:           It’s really great.
 
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IMPORTANT SAFETY INFORMATION

[VENCLEXTA LOGO]

Important Safety Information

What is the most important information I should know about VENCLEXTA?

VENCLEXTA can cause serious side effects, including: Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. Your healthcare provider will do tests to check your risk of getting TLS before you start taking VENCLEXTA. You will receive other medicines before starting and during treatment with VENCLEXTA to help reduce your risk of TLS. You may also need to receive intravenous (IV) fluids into your vein. Your healthcare provider will do blood tests to check for TLS when you first start treatment and during treatment with VENCLEXTA. It is important to keep your appointments for blood tests. Tell your healthcare provider right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.

Drink plenty of water during treatment with VENCLEXTA to help reduce your risk of getting TLS. Drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before your first dose, on the day of your first dose of VENCLEXTA, and each time your dose is increased.

Your healthcare provider may delay, decrease your dose, or stop treatment with VENCLEXTA if you have side effects. When restarting VENCLEXTA after stopping for 1 week or longer, your healthcare provider may again check for your risk of TLS and change your dose.

Who should not take VENCLEXTA?

Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased because of the risk of increased TLS.

  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VENCLEXTA and other medicines may affect each other causing serious side effects.
  • Do not start new medicines during treatment with VENCLEXTA without first talking with your healthcare provider.
     

Before taking VENCLEXTA, tell your healthcare provider about all of your medical conditions, including if you:

  • have kidney or liver problems.
  • have problems with your body salts or electrolytes, such as potassium, phosphorus, or calcium.
  • have a history of high uric acid levels in your blood or gout.
  • are scheduled to receive a vaccine. You should not receive a “live vaccine” before, during, or after treatment with VENCLEXTA, until your healthcare provider tells you it is okay. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. These vaccines may not be safe or may not work as well during treatment with VENCLEXTA.
  • are pregnant or plan to become pregnant. VENCLEXTA may harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with VENCLEXTA, and you should use effective birth control during treatment and for 30 days after the last dose of VENCLEXTA. If you become pregnant or think you are pregnant, tell your healthcare provider right away.
  • are breastfeeding or plan to breastfeed. It is not known if VENCLEXTA passes into your breast milk. Do not breastfeed during treatment with VENCLEXTA and for 1 week after the last dose.

What should I avoid while taking VENCLEXTA?

You should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. These products may increase the amount of VENCLEXTA in your blood.

What are the possible side effects of VENCLEXTA?

VENCLEXTA can cause serious side effects, including:

  • Low white blood cell counts (neutropenia). Low white blood cell counts are common with VENCLEXTA, but can also be severe. Your healthcare provider will do blood tests to check your blood counts during treatment with VENCLEXTA and may pause dosing.
  • Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with VENCLEXTA. Your healthcare provider will closely monitor and treat you right away if you have a fever or any signs of infection during treatment with VENCLEXTA.

Tell your healthcare provider right away if you have a fever or any signs of an infection during treatment with VENCLEXTA.

The most common side effects of VENCLEXTA when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell counts; low platelet counts; low red blood cell counts; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of your arms, legs, hands, and feet.

VENCLEXTA may cause fertility problems in males. This may affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of VENCLEXTA. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

If you cannot afford your medication, contact genentech-access.com/patient/brands/venclexta for assistance.

Please see Full Prescribing Information, including Medication Guide on www.VENCLEXTA.com or at www.rxabbvie.com/pdf/venclexta.pdf

 

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